BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6600375 · Received May 31, 2017

    Report

    Report Number
    3004123209-2017-00550
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 23, 2017
    Report Date
    August 31, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 24TH OF DECEMBER 2013. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2014 AND PERFORMED ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON (B)(6) 2016. THERE WERE FIVE MANUAL POWER UPS, OF TEN MINUTES' DURATION, OBSERVED IN THE DEVICE MEMORY ON (B)(6) 2016. THE DEVICE SUCCESSFULLY PERFORMS ALL WEEKLY AUTO SELF-TESTS BETWEEN THE 10TH OF JULY 2016 AND THE 30TH OF APRIL 2017. ON (B)(6) 2017, THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO LOW BATTERY. THE DEVICE RECORDS TWO LOG ENTRIES OF NONSENSICAL DURATION AND NONSENSICAL DATA ON (B)(6) 2017. NO FURTHER LOG ENTRIES WERE RECORDED PRIOR TO RECEIPT AT HEARTSINE. THE RETURNED PAD-PAK WAS DISASSEMBLED TO INVESTIGATE AND THE BATTERY CELLS WERE MEASURED INDIVIDUALLY. FIVE OF THE CELLS SHOWED SIMILAR DEPLETION WHILE THE REMAINING CELL WAS FOUND TO BE SIGNIFICANTLY MORE DEPLETED THAN THE OTHERS. THE RETURNED PAD-PAK DHR WAS INVESTIGATED SHOWING IT WAS 1 OF (B)(4) PAD-PAK'S MANUFACTURED UNDER LOT B1007, (B)(4) OF WHICH WERE SENT TO HST INC ON THE 20TH OF AUGUST 2014. ALL PAD-PAK'S WERE SUBJECTED TO A BATTERY VOLTAGE TEST WITH NO RECORDED FAILS. THIS WOULD INDICATE THE RETURNED PAD-PAK BECAME DEPLETED AFTER DISPATCH FROM HEARTSINE. THE DEVICE WAS TESTED ON THE CALIBRATED DEFIBRILLATOR ON THE 10TH OF JULY 2017 AND THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. THE INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO A FAULTY BATTERY CELL IN THE RETURNED PAD-PAK. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. RED STATUS INDICATOR. PAD-PAK EXPIRY 10/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384355 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1